Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have unresectable primary or metastatic liver cancer.


Study summary:

OBJECTIVES: - Evaluate the nature and duration of response of patients with primary or metastatic liver neoplasms, who are not candidates for surgical resection, treated with radiofrequency interstitial tissue ablation. - Evaluate the ability of dynamic magnetic resonance imaging (MRI) to assess the effects of this therapy on tumor blood flow and tumor vascular density in these patients. - Determine the ability of positron emission tomography with fludeoxyglucose F 18 (FDG-PET) to monitor response after treatment with this therapy in these patients. - Compare FDG-PET results with computed tomography (CT) scan, biopsy, and serum marker results in patients treated with this therapy. - Compare the performance of FDG-PET with CT scan and MRI, in terms of their ability to assess the efficacy of this therapy in these patients. OUTLINE: Lesions are targeted by ultrasound and then radiofrequency ablation needles are inserted into the lesions and heated to a target temperature greater than 60 degrees C for 15 minutes, though exposure time may vary depending on temperatures achieved. To achieve a 1 cm margin of ablated tissue around each lesion, multiple ablation courses may be performed, depending on the size of the lesions and the time required to complete the treatment. Patients undergo magnetic resonance imaging with gadopentetate dimeglumine contrast, CT scan, ultrasound, and positron emission tomography with fludeoxyglucose F 18 at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years. Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years or until evidence of recurrence. PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study within 6 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed primary or metastatic liver lesions - Not a candidate for surgical resection - Must have six or fewer lesions and no single lesion greater than 7 cm in diameter - Extrahepatic disease allowed PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: - At least 3 months Hematopoietic: - Platelet count at least 50,000/mm^3 - Prothrombin time (PT) or partial thromboplastin time (PTT) no greater than 1.5 times control (except for therapeutically anticoagulated nonrelated medical conditions [e.g., atrial fibrillation]) Hepatic: - Bilirubin no greater than 3.0 mg/dL Renal: - Creatinine no greater than 2.5 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - No pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices - No known uncontrollable serious reactions (e.g., anaphylaxis) to contrast agents used in this study - Weight less than 136 kg PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - Concurrent systemic therapy for extrahepatic disease is allowed only if begun prior to radiofrequency ablation


NCT ID:

NCT00019604


Primary Contact:

Principal Investigator
Steven A Libutti, MD
National Cancer Institute, National Institutes of Health


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

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